510(k) · Cleared
ClearedCurvaFix Low Profile System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curvafix, Inc. · HWC Screw, Fixation, Bone
Cleared on Aug 29, 2025 as substantially equivalent to K222505 (Curvafix, Inc., 2022) and 2 other predicates after a 60-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Aug 29, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K962616 (1996). 237 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
- 2 generations backK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- 1 generation backK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- This deviceK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 7 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 6 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 5 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 4 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 3 generations backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
- 2 generations backK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- 1 generation backK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- This deviceK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −7 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −6 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −5 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −4 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −3 | K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | 2018 | — |
| −2 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
| −1 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| 0 (this device) | K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 12 | 0 |
| 1996 | 14 | 0 |
| 1997 | 9 | 0 |
| 1998 | 12 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 18 | 0 |
| 2002 | 18 | 0 |
| 2003 | 7 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 12 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222505 | CurvaFix IM SystemSummary page 5…FR §888.3030 Regulatory Classification: 2 Product Code: HWC, HTN Predicate Devices: Primary: CurvaFix IM System (K222505) Additional: CurvaFix Intramedullary Rodscrew System (K180050) Additional: Smit… | 2022 |
| * | K180050 | CurvaFix Intramedullary Rodscrew SystemSummary page 5…Product Code: HWC, HTN Predicate Devices: Primary: CurvaFix IM System (K222505) Additional: CurvaFix Intramedullary Rodscrew System (K180050) Additional: Smith & Nephew Cannulated Screws & Washers (K213126) Device Description: The CurvaFix Low… | 2019 |
| * | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Summary page 5…) Additional: CurvaFix Intramedullary Rodscrew System (K180050) Additional: Smith & Nephew Cannulated Screws & Washers (K213126) Device Description: The CurvaFix Low Profile System is a collection of flexible intramedullary devices for pelvic fracture fixa… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 46 of the 237 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The CurvaFix® Low Profile System is intended for fixation of fractures of the pelvis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252019: CurvaFix Low Profile System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026